Overweight Clinical Trial
Official title:
Effect of Different Intensity Resistance Training on Energy Intake and Appetite Regulation Among Overweight and Obese College Girl
Verified date | September 2022 |
Source | Universiti Putra Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Resistance training is a common way of daily exercise which has a remarkable function in healthcare. It has been used in many diseases as a complementary method. Overweight and obesity are the sixth highest risk of death worldwide. In recent years, the data show that the rate of overweight obese among college students shows a significant increasing trend. The common characteristics of overweight and obese people are strong appetite which is difficult to be controled and sedentary. resistance training is a solid supplement to physical education and how to reduce appetite of overweight and obese college female students through resistance training is the key to increase their health by university sport course. The training plan divides the training intensity into three levels including 45-50% one repetition maximum(1RM), 60-65% 1RM, 45-50% 1RM, respectively plus control group. Therefore, this experimental research examines the effectiveness and the differences of three Intensities resistance training on energy intake and appetite regulation among overweight and obese college girl. Finally, to evaluate whether the resistance training can reduce the overweight and obese female college students' energy intake and appetite regulation
Status | Enrolling by invitation |
Enrollment | 72 |
Est. completion date | December 1, 2023 |
Est. primary completion date | October 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 22 Years |
Eligibility | Inclusion Criteria: 1. Overweight or obese (BMI> 25) 2. Female 3. College students 4. Healthy Exclusion Criteria: 1. The subjects lack regular and active exercise program in last three months 2. The subjects are not on a diet in last three months. c, Do not have regular menstrual cycle or approaching the normal menstrual cycle |
Country | Name | City | State |
---|---|---|---|
China | YiChun Education College | Yichun | Jiangxi |
Lead Sponsor | Collaborator |
---|---|
Universiti Putra Malaysia |
China,
Bales CW, Hawk VH, Granville EO, Rose SB, Shields T, Bateman L, Willis L, Piner LW, Slentz CA, Houmard JA, Gallup D, Samsa GP, Kraus WE. Aerobic and resistance training effects on energy intake: the STRRIDE-AT/RT study. Med Sci Sports Exerc. 2012 Oct;44(1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline BMI at 6 weeks and 12 weeks. | This parameter belongs to Obesity Degree. | Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline body fat percentage at 6 weeks and 12 weeks. | This parameter belongs to Obesity Degree. | Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline waist circumference at 6 weeks and 12 weeks. | This parameter belongs to Obesity Degree. | Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline energy intake at 6 weeks and 12 weeks. | This parameter will be recorded by Quantitative Daily Dietary Intake (QDI): three multiple-pass 24-hr recalls collected at each assessment time point by a research dietitian/technician. Analysis by Food Processor Nutrition Analysis Software (Version 9.6, 2005, ESHA Research, Salem, OR): recalls are analysed for calorie and macronutrient content | Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline hunger at 6 weeks and 12 weeks. | This parameter will be test by 100-mm visual analogue scale (VAS): test at 6:00-8:00 am following a 10h overnight fast, rate perceive appetite firstly. Then provide with a standardised caloric stimulus, at 30, 60, 90 and 120min post consumption rate perceived appetite again (r = 0.42 - 0.85).
At every time point, both lengths of VAS 100 mm were used to record desire to eat, hunger, fullness, and prospective food consumption. The four standardized questions were: (i) how strong is your desire to eat? ("very weak" to "very strong"), (ii) how hungry do you feel? ("not hungry at all" to "as hungry as I've ever felt"), (iii) how full do you feel? ("not full at all" to "very full"), and (iv) how much food do you think you can eat? (Prospective food consumption; "nothing at all" to "a large amount") . |
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline fullness at 6 weeks and 12 weeks. | This parameter will be test by 100-mm visual analogue scale (VAS): test at 6:00-8:00 am following a 10h overnight fast, rate perceive appetite firstly. Then provide with a standardised caloric stimulus, at 30, 60, 90 and 120min post consumption rate perceived appetite again (r = 0.42 - 0.85).
At every time point, both lengths of VAS 100 mm were used to record desire to eat, hunger, fullness, and prospective food consumption. The four standardized questions were: (i) how strong is your desire to eat? ("very weak" to "very strong"), (ii) how hungry do you feel? ("not hungry at all" to "as hungry as I've ever felt"), (iii) how full do you feel? ("not full at all" to "very full"), and (iv) how much food do you think you can eat? (Prospective food consumption; "nothing at all" to "a large amount") . |
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline desire to eat at 6 weeks and 12 weeks. | This parameter will be test by 100-mm visual analogue scale (VAS): test at 6:00-8:00 am following a 10h overnight fast, rate perceive appetite firstly. Then provide with a standardised caloric stimulus, at 30, 60, 90 and 120min post consumption rate perceived appetite again (r = 0.42 - 0.85).
At every time point, both lengths of VAS 100 mm were used to record desire to eat, hunger, fullness, and prospective food consumption. The four standardized questions were: (i) how strong is your desire to eat? ("very weak" to "very strong"), (ii) how hungry do you feel? ("not hungry at all" to "as hungry as I've ever felt"), (iii) how full do you feel? ("not full at all" to "very full"), and (iv) how much food do you think you can eat? (Prospective food consumption; "nothing at all" to "a large amount") . |
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline prospective food consumption at 6 weeks and 12 weeks. | This parameter will be test by 100-mm visual analogue scale (VAS): test at 6:00-8:00 am following a 10h overnight fast, rate perceive appetite firstly. Then provide with a standardised caloric stimulus, at 30, 60, 90 and 120min post consumption rate perceived appetite again (r = 0.42 - 0.85).
At every time point, both lengths of VAS 100 mm were used to record desire to eat, hunger, fullness, and prospective food consumption. The four standardized questions were: (i) how strong is your desire to eat? ("very weak" to "very strong"), (ii) how hungry do you feel? ("not hungry at all" to "as hungry as I've ever felt"), (iii) how full do you feel? ("not full at all" to "very full"), and (iv) how much food do you think you can eat? (Prospective food consumption; "nothing at all" to "a large amount") . |
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline glucose at 6 weeks and 12 weeks. | Blood is collected into Vacutainers (BectonDickinson, Franklin Lakes, NJ) containing SST Gel (Becton Dickinson), Ethylenediaminetetraacetic acid(EDTA), or heparin and is immediately placed on ice and centrifuged (4 C, 1500g, 15 min). The serum or plasma obtained is stored in multiple aliquots at 75 C until assayed (in duplicate).
Glucose is determined by the glucose oxidase method (Sigma-Aldrich Corp; 3.8% and 4.9% inter- and intraassay coefficients of variation) (70~140mg/dl or 3.9~7.8mmol/l) |
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline leptin at 6 weeks and 12 weeks. | Blood is collected into Vacutainers (BectonDickinson, Franklin Lakes, NJ) containing Serum-separating tube(SST) Gel (Becton Dickinson), EDTA, or heparin and is immediately placed on ice and centrifuged (4 C, 1500g, 15 min). The serum or plasma obtained is stored in multiple aliquots at 75 C until assayed (in duplicate).
Serum leptin is determined by an ELISA with a commercially available kit (EIA-2395, DRG, Marburg, Germany; 5.9% intraassay precision; 6.8% interassay accuracy; sensitivity of 0.5ng/ml). |
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline adiponectin at 6 weeks and 12 weeks. | Blood is collected into Vacutainers (BectonDickinson, Franklin Lakes, NJ) containing SST Gel (Becton Dickinson), EDTA, or heparin and is immediately placed on ice and centrifuged (4 C, 1500g, 15 min). The serum or plasma obtained is stored in multiple aliquots at 75 C until assayed (in duplicate).
Plasma adiponectin is analysed with a commercially available radioimmunoassay (RIA) (Linco Research, Inc., St. Charles, mo; 6.9% intraassay precision; 7.8% interassay accuracy; sensitivity of 0.5ng/ml.) (3~30µg/mL). |
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline NPY at 6 weeks and 12 weeks. | Blood is collected into Vacutainers (BectonDickinson, Franklin Lakes, NJ) containing SST Gel (Becton Dickinson), EDTA, or heparin and is immediately placed on ice and centrifuged (4 C, 1500g, 15 min). The serum or plasma obtained is stored in multiple aliquots at 75 C until assayed (in duplicate).
Neuropeptide Y is measured by Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) (NPY; Phoenix Europe Gesellschaft mit beschränkter Haftung (GmbH), Karlsruhe, Germany; Sensitivity of 0.13 ng/ml; Intra-assay variability <5%) (51.23~209.65 pg/ml). |
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline Insulin at 6 weeks and 12 weeks. | Blood is collected into Vacutainers (BectonDickinson, Franklin Lakes, NJ) containing SST Gel (Becton Dickinson), EDTA, or heparin and is immediately placed on ice and centrifuged (4 C, 1500g, 15 min). The serum or plasma obtained is stored in multiple aliquots at 75 C until assayed (in duplicate).
Insulin is measured with an immunoassay (Access Immunoassay System, Beckman Coulter, Fullerton, California (CA); 4.9% intraassay precision; 3.8% interassay accuracy; sensitivity of 0.5 µu/ml) (60-100mg/dl). |
Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline meal-time at 6 weeks and 12 weeks. | This parameter record by Quantitative Daily Dietary Intake (QDI): three multiple-pass 24-hr recalls collected at each assessment time point by a research dietitian/technician. Analysis by Food Processor Nutrition Analysis Software (Version 9.6, 2005, ESHA Research, Salem, OR): recalls are analysed for the percentage of day and night total kcals intake separately. | Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline stress of eating at 6 weeks and 12 weeks. | This parameter measured by The Salzburg Stress Eating Scale (SSES) which is the first to specifically address the relationship of stress experiences and coping failure on the one hand and increases or decreases in food intake on the other hand. Higher SSES scores indicate eating more when stressed, while lower scores indicate eating less when stressed. | Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. | |
Primary | Change from baseline physical activity level at 6 weeks and 12 weeks. | This parameter measured by Global Physical Activity Questionnaire (GPAQ). The GPAQ covers several components of physical activity, such as intensity, duration, and frequency, and it assesses three domains in which physical activity is performed (occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time) comprising 16 questions (P1-P16). Since it was developed by World Health Organization (WHO) in 2002, the GPAQ has undergone a research program which shows that it is valid and reliable. It has become the most common tool in diagnostic and evaluation studies of physical activity globally. | Pretest: Before experiment; Mid-test: 6 weeks end; Post-test: 12 weeks end. |
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